SHANGHAI, China- Shanghai Juncell Therapeutics Co., Ltd. (Juncell Therapeutics), a biotechnology company focused on the research, development, and commercialization of cell therapies for the treatment of solid tumors, announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Priority Review to Nolgileucel (GC101), for the patients with unresectable or metastatic melanoma who have previously failed at least two piror lines of systemic therapy (including PD-1 inhibitors).

"The Priority Review granted to China's first TIL therapy indicates the NMPA's recognition of the efficacy and safety of this innovative TIL therapy, and demonstrates its great potential in the treatment of advanced melanoma. We will fully cooperate with the NMPA in its review and inspection processes, and accelerate the development of TIL therapy to benefit more patients as soon as possible." Founder, CEO & CTO of Juncell Therapeutics, Dr. Huajun Jin said.

This year, Nolgileucel has been successively featured presentations at ASCO, CSCO and ESMO, three top global oncology conferences, making it the only oncology innovative drug to date to be featured at three top global oncology conferences. This represents domestic and international recognition of the study's innovative value and urgent expectation of its clinical translation potential.

On October 26th, the New Drug Application (NDA) for Nolgileucel has been accepted by China's National Medical Products Administration (NMPA). This innovative TIL therapy is transitioning from the forefront of international academic research to clinical translation, making cutting-edge cell therapy accessible to patients in China. We will continuously committed to our mission "Rebuild Cells, Rescue Lives", and accelerate innovative therapies to benefit more patients with solid tumors.